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Was Generika sind und wie sie sich von Markenarzneimitteln unterscheiden

What generics are and how they differ from branded medicines

Definition of generics

Generics are imitations of branded drugs that come onto the market after patent protection has expired. They contain the same active ingredient as the original product and are usually offered at a lower price. Generics must meet the same strict quality and safety standards as branded drugs and are subject to approval by the pharmaceutical authorities. They are usually manufactured by different companies than the original branded drugs, which leads to competition on the pharmaceutical market.

Differences to branded pharmaceuticals:

A significant difference between generics and branded pharmaceuticals lies in their cost structure. Since generics have no costs for research and development or marketing, they can be offered at a lower price. This allows patients to purchase medicines at a more affordable price.

Another distinction is the packaging and appearance. Generics often have a different appearance, color or shape compared to branded drugs. However, this has no influence on the efficacy or safety of the medicine, as the active ingredients and their quantity are identical.

Generics are an important alternative to branded medicines, as they have the same therapeutic effect but can be offered at a lower price. They help to reduce healthcare costs and give patients easier access to medicines.

What are generics?

Generics are imitation products of branded drugs that are manufactured and sold after the patent has expired. They contain the same active ingredients as the original drug and have the same efficacy and safety. The production of generics are produced by various pharmaceutical companies that analyze and reproduce the original drug in detail. However, the manufacturers do not have to bear the high development costs, as the patent on the original drug has expired. This means that generics can be offered at a significantly lower price.

Generics have established themselves on the market and are a popular and trusted alternative to branded medicines. They are just as safe and effective as the original and are often prescribed by doctors to reduce healthcare costs. Generics are not exclusively limited to prescription drugs, but can also be found in many over-the-counter medicines.

Overall generics offer consumers the opportunity to purchase high-quality medicines at an affordable price. The production of generics plays an important role in increasing the availability of medicines and ensuring fair competition in the pharmaceutical market. It is important to note that generics always contain the same active ingredients as the original, but may have different excipients or dosage forms.

Same active ingredients

Generics are copycat drugs that contain the same active ingredient as the original branded drug, but are offered at a lower price. The same active ingredients play an important role in genericsas they are intended to achieve the same therapeutic effect as the original medication.

Bioavailability determines the interchangeability of the generics. It describes how quickly and to what extent the active ingredient is absorbed in the body after administration. Generics must have the same bioavailability as the original drug according to pharmacokinetic criteria in order to be considered equivalent. This means that the active substance in the generic must enter the body and take effect with the same speed and efficiency as the original drug.

Excipients can nevertheless have an influence on the effect of the generics of generics. These additives are used to improve the stability, shelf life or taste of the medicine. In some cases, however, they may affect the tolerability or efficacy of the active ingredient. It is important that the excipients in the generics are sufficiently tested to ensure that they are compatible with the active ingredient and do not interfere with the desired effect.

Overall generics medicines that contain the same active ingredients as branded medicines and are intended to achieve the same therapeutic effect. By taking into account the bioavailability and ensuring the tolerability and efficacy of the excipients generics can offer a cost-effective alternative to the original medication.

Approval procedure for new drugs

The approval process for new drugs in the USA is very strictly regulated. The US Food and Drug Administration (FDA) reviews and approves each generic version of a drug to ensure that it is bioequivalent to the original. Bioequivalence means that the generic contains the same amount of the active ingredient and is absorbed in the body under the same conditions as the original drug.

To be recognized as a new generic a drug must meet strict requirements. In addition to the correct amount of the active ingredient, the generic must also comply with Good Manufacturing Practices to ensure the quality and purity of the manufactured product. These standards are set and monitored by the FDA.

The main difference between original medicines and generics is that generics contain the same active ingredient as the original drug, but are usually offered at a lower price. This is because generics can be produced after the patent protection of the original drug has expired. It is important to emphasize that generics must prove through bioequivalence studies that they have the same efficacy and safety as the original drug.

The FDA's approval process for new drugs ensures the high quality and safety of generics and ensures that patients have access to cost-effective alternatives. Through strict adherence to bioequivalence and Good Manufacturing Practices, patients can rest assured that generics are just as effective and safe as the corresponding branded medicines.

Federal Institute for Drugs and Medical Devices

The Federal Institute for Drugs and Medical Devices (BfArM) is a German higher federal authority responsible for the approval, control and monitoring of drugs and medical devices. The BfArM has the task of ensuring drug safety in Germany and protecting the health of the population.

The main task of the BfArM is the approval of medicinal products. Drugs must be approved by the BfArM before they can be launched on the market. Extensive scientific data is reviewed and evaluated in order to ensure the efficacy, safety and quality of a medicinal product. The BfArM also monitors the entire life cycle of a medicine, from manufacture to use.

The Medicines Agency also contributes to the monitoring of drug safety. It collects and evaluates information on adverse drug reactions (side effects) and, if necessary, takes measures to ensure patient safety.

In addition to medicinal products, the BfArM also regulates medical devices such as implants or medical devices. It ensures that these products comply with the applicable safety and quality standards.

Overall, the Federal Institute for Drugs and Medical Devices plays an important role in ensuring drug safety in Germany and contributes to the health of the population.

Differences to branded medicines

Generics are medicines that contain the same active ingredient as a branded medicine but are significantly cheaper. They are produced by other manufacturers as soon as the patent for the branded drug has expired. Although generics contain the same active ingredients, they may differ from branded drugs in some aspects. Here are some differences to branded medicines:

1. priceThe biggest difference between generics and branded drugs lies in the price. Generics are generally much cheaper than their branded equivalents. This is because generic manufacturers do not have the same research and development costs as manufacturers of branded drugs.

2. appearance: Generics can often look different from branded drugs. Although they contain the same active ingredient, they may generics may be designed differently or manufactured with different colors or shapes. However, these differences do not affect the quality or effectiveness of the medicine.

3. packagingThe packaging of generics may also differ from that of branded medicines. Generics are often offered in simpler packaging in order to save costs.

4. manufacturer: Generics are produced by different manufacturers than branded drugs. This means that different pharmaceutical companies generics companies can produce generics, creating more competition in the market.

In conclusion generics offer a cheaper alternative to branded drugs. They contain the same active ingredient and are just as safe and effective, but at a fraction of the price. It is important that patients and consumers are informed about the differences to branded medicines so that they can make informed decisions.

Reference medicines

Reference medicines are medicines originally developed and manufactured by a pharmaceutical company and available under a brand name. These drugs usually have patent protection, which allows the company to have the exclusive right to sell and market the drug for a certain period of time.

Patent protection guarantees the manufacturer a monopoly position, as no other companies are allowed to offer the same medicine under the same brand name. This allows the manufacturer to set the price for the reference medicine and aim to make a profit.

After patent protection expires, other companies can generics and bring them onto the market. Generics are medicines that contain the same active ingredient as the reference medicine but are sold under a different name. They have no brand loyalty and are usually cheaper than the original medicine. Generics are similar in their efficacy and safety and must meet the same strict regulatory requirements as the original medicine.

The section on reference medicinal products is relevant as it provides the background for the creation of generics and the difference between branded medicinal products and Generics explained. Patent protection and the exclusive marketing of reference drugs enable manufacturers to set high prices, while generics can act as a cost-effective alternative. Generics therefore play an important role in ensuring price competition in the pharmaceutical market and improving access to affordable medicines.

Compulsory prescription

In the US, many drugs are subject to prescription, which means that they are only available with a doctor's order. This concept serves to ensure the safe use of medicines and minimize potential risks.

Generics are imitation preparations of branded drugs that can be manufactured after patent protection has expired. They contain the same active ingredient and work in exactly the same way as the original medicine. The only difference is in the excipients, which are required for taste and processing and generally have no effect on efficacy.

Generics have taken an important place in the market for prescription drugs in the USA. One reason for this is that generics are generally less expensive than branded drugs. On the other hand, prescription-only laws make them an alternative option for patients who cannot afford the cost of the original medicine.

According to estimates generics account for more than 80% of the market for prescription drugs in the USA. This high market share shows that generics play an important role in supplying the population with medicines and helping to improve access to healthcare.

Cost differences

Generics are imitation products of patent-protected medicines. They contain the same active ingredients in the same dosage and must meet the same quality and safety standards as the original preparations. The main difference between generics and branded drugs, however, is the cost.

Generics are significantly cheaper than patent-protected medicines. This is because generics manufacturers do not have expensive research and development costs. They can simply reproduce existing medicines. For this reason generics can be offered at a fraction of the price of initial supplier products.

In 2021, the average prices for generics are around 30-80% lower than the prices of patent-protected medicines. This means that patients can make significant savings if they opt for generics opt for generics.

The cost differences between generics and patent-protected drugs are an important factor when deciding on a treatment option. Generics are a cost-effective alternative that offer the same efficacy and safety as the more expensive branded drugs. By choosing generics patients can save considerably without having to compromise on the quality of treatment. Therefore, the cost differences between generics and patent-protected drugs are of great importance for the healthcare system and patients.

Availability and use of generics

A generic is a copy of an existing branded drug that is produced after patent protection has expired. The elimination of research and development costs means that generics can be offered at a lower price. Generics contain the same active ingredients as branded pharmaceuticals and meet the same quality and efficacy standards. They can be available in various forms such as tablets, capsules or liquid solutions. Generics are usually manufactured by different pharmaceutical companies and can be marketed under different trade names. An important distinction between generics and branded drugs is the price. Generics are generally considerably cheaper than branded drugs. This enables broader access to medical care and cost savings for patients and the healthcare system as a whole. Generics are widely available in many countries, including Germany, and are often prescribed by healthcare professionals. They offer an affordable alternative to branded medicines and contribute to the efficiency of the healthcare system.

Statutory health insurance cover

Statutory health insurance cover in Germany is compulsory for the entire population. Everyone who lives in Germany and does not have a high income is obliged to register with a health insurance fund and pay contributions. These contributions give the insured person access to medical care, including visits to the doctor, hospital stays, medication and therapies.

In connection with generics and branded drugs, statutory health insurance cover plays an important role. Generics are imitation products of original branded drugs that come onto the market when the patent protection of the original drug has expired. The statutory health insurance funds are obliged to generics and to contribute to cost-effective care. This means that a patient who is prescribed a branded drug is entitled to a generic if an equivalent medicine is available.

The market entry of generics has a direct influence on the price of the original preparation. Competition between several generics manufacturers means that the price of medicines falls considerably. As a result, the statutory health insurance funds have to pay less for the care of their policyholders. It is worth noting that the quality and efficacy of generics is ensured by a strict evaluation and approval process. Therefore generics are a reliable alternative to branded drugs and enable cost-effective treatment for patients.

Ratings from Stiftung Warentest

Generics are imitation products of branded medicines already on the market. They contain the same active ingredient as the original product, but are usually cheaper. Generics are becoming increasingly popular as they are a cost-effective alternative to expensive branded drugs.

Stiftung Warentest has generics under the microscope several times and evaluated various criteria. These include efficacy, tolerability, application and price. The evaluation criteria of Stiftung Warentest play an important role for consumers, as they provide an objective assessment of the quality and benefits of generic drugs. generics products.

Stiftung Warentest's evaluations are of great importance to consumers, as they help them to decide for or against generic drugs. generics generics. Stiftung Warentest's evaluation criteria provide consumers with important information about the efficacy, tolerability and price of generic drugs. generics. This enables them to make an informed decision and save money by choosing cheap generics. generics products.

European regulations on generics

Generics are copycat drugs that are comparable to branded drugs already on the market in terms of efficacy, quality and safety. They contain the same active ingredient as the original product, but have a lower price due to the expiry of patent protection.

In Europe, there are clear regulations for generics. They are subject to the same strict approval procedures as branded drugs and must meet the same safety and quality requirements. The European regulation stipulates that a generic demonstrably contains the same amount of active ingredient as the original, has similar pharmacokinetic properties and is effective at the same site in the body.

These regulations on the sale and quality of medicines ensure that generics are a safe and cost-effective alternative to branded medicines. They enable consumers to purchase high-quality medicines at lower prices and help to reduce costs in the healthcare system. The European regulation ensures that the development and sale of generics are strictly monitored to protect the interests of patients.

Overall generics offer an affordable option for the treatment of diseases in Europe and allow consumers to reduce the cost of their medicines without compromising on quality and safety.

Manufacturers of generics

Manufacturer of generics are pharmaceutical companies that produce drugs that contain the same active ingredient as branded drugs already on the market. The difference is that generics can be produced after the patent protection of the original drug has expired and are therefore cheaper.

In Germany, there are several well-known manufacturers of generics. Among the most prominent are Ratiopharm, Hexal, Stada, Teva, Mylan and Actavis. Ratiopharm and Hexal are subsidiaries of the large pharmaceutical group Novartis. They specialize in the production of high-quality generics and offer a wide range of medicines in various therapeutic areas. Stada is a German manufacturer of generics and other pharmaceutical products. The company specializes in various areas such as diabetes, cardiovascular diseases and pain therapy. Teva, Mylan and Actavis are international manufacturers of generics based in various countries.

In summary, the manufacturers of generics are important players on the pharmaceutical market. They represent a cost-effective alternative to branded drugs and thus provide many patients with access to essential medicines.

Competition on the market

Generics are copycat drugs that contain the same active ingredient as branded drugs but are offered at a lower price. The market for generics is characterized by intense competition, as various companies want to produce and sell similar drugs.

An important difference between generics and branded drugs lies in their legal situation. Branded drugs are protected by patents that prohibit other companies from producing the same drug under the same name. This gives branded drugs a monopoly on the market, allowing them to charge higher prices for their products. However, once the patent has expired, other companies can generics and sell them, which leads to increased competition and lower prices.

Generics must guarantee the same efficacy, safety and quality as branded drugs, as they contain the same active ingredient. However, they do not have to have exactly the same composition as the branded medicine. This means that generics may contain slightly different excipients or fillers, but these have no influence on the effectiveness of the medicine.

Overall, they offer generics offer a cost-effective alternative to branded drugs and thus contribute to competitiveness in the pharmaceutical market. The choice between generics and branded drugs, consumers have the opportunity to reduce their medication costs without compromising on efficacy and quality.

What is a generic?

A genericalso known as a generic drug, is a drug that contains the same active ingredient as a branded drug already on the market. It is produced by another manufacturer after the patent on the original medicine has expired.

Generics are characterized by their equivalence and quality to branded medicines. They contain the same active ingredient, in the same dosage and dosage form as the original medicine. This means that generics have the same therapeutic efficacy and safety as branded drugs.

The main difference between generics and branded drugs lies in the price. Because generics can be produced by different manufacturers, competition is greater, which leads to a lower price. Generics therefore provide a more cost-effective alternative to branded drugs, which is particularly advantageous for long-term treatment of chronic diseases.

It is important to note that generics must meet strict regulations in order to be approved for the market. They must prove that they are bioequivalent to their branded counterparts, which means that they act in the same way in the body and offer the same efficacy and safety. Through the use of generics can reduce healthcare costs by replacing more expensive branded medicines with cheaper alternatives.

How do I recognize generics?

Generics are imitation products of branded drugs that come onto the market after patent protection has expired. They contain the same active ingredient as the original medicine and have a similar quality and effectiveness. The main difference is that generics are generally cheaper than the original preparations.

One possibility, generics can be recognized by the name. They often contain generics contain the name of the active ingredient or its abbreviation. Instead of a catchy and distinctive brand name generics often have a descriptive name that refers directly to the active ingredient. For example, the well-known painkiller "Aspirin" is sold as "acetylsalicylic acid" in its generic form.

Doctors are not obliged to prescribe a generic drug instead of the original drug. generic instead of the original drug. They decide which medicine is most suitable depending on the patient's individual needs. However, it is possible to ask the doctor for a generic especially if the price plays a role.

In the pharmacy you can ask specifically for generics at the pharmacy. Pharmacists are trained to offer alternative options and provide information about different medications. They can help you choose between generics and branded medicines and answer questions about costs, dosage and possible side effects.

Generics offer patients a cheaper alternative to branded medicines. By paying attention to the name of the active ingredient and communicating with the doctor and pharmacist, you can make the right decision for your own health.

Have generics the same quality as the original?

Generics are medicines that contain the same active ingredient as the original medicine and have similar therapeutic effects. They are manufactured after the patent protection of the original medicine has expired and are generally cheaper. Generics differ from branded drugs in a number of important aspects.

The quality of generics compared to the original may vary. Generics must contain the same active ingredient and have a similar bioavailability as the original medicinal product. This means that the active ingredient is absorbed and metabolized similarly in the body. The safety and quality of generics are regulated by specific requirements to ensure that they correspond to the original medicinal product.

The authorization of generics is based on a shortened approval procedure known as a bioequivalence study. In this study generics are compared with the original medicinal product in order to determine bioavailability. The manufacturers of generics must prove that their products offer the same therapeutic benefit and safety as the original medicinal product.

The requirements for generics in terms of safety and quality are high. Manufacturers must adhere to strict production standards and regularly test their medicines for efficacy and safety. Before generics come onto the market, they must receive approval based on the same quality and safety standards as the original medicine.

Overall generics offer an effective and inexpensive alternative to branded medicines. Although they have the same active ingredient, they may differ from branded medicines in some aspects such as appearance, color or packaging. It is important that patients and doctors are aware that generics are approved under strict requirements and are of high quality.

What distinguishes a generic from the first supplier preparation?

A generic is a type of medicine that differs from a first supplier preparation. The main difference concerns the name, color and shape of the medicine. However, the active ingredient is identical.

Generics are produced after the patent of the first supplier's product has expired and are generally cheaper than the original product. This is because the manufacturers of generics do not have to bear the costs of research and development. Generics must, however, meet the same quality and efficacy standards as the original product.

The different names, colors and shapes of the generics have no influence on the effect of the medicine. These differences result from the fact that generic manufacturers are allowed to sell the medicine under a different brand name and can therefore give it its own appearance.

Another difference concerns the excipients that may be contained in the medicines. Generics may contain different excipients than the first supplier product, but this does not normally affect the effect of the active ingredient. Allergies or intolerances to these excipients are extremely rare.

In summary, it can be said that generics can be distinguished from first supplier preparations mainly by their name, color and shape. However, the active ingredient is identical and allergies or intolerances to the excipients are extremely rare.

Which diseases are treated with generics treated?

Generics are medicines that are identical in their composition of active ingredients to branded medicines already on the market. However, they are offered at a lower price. Generics are used for a variety of diseases and complaints. They are used particularly frequently for common diseases such as asthma, high blood pressure, diabetes and osteoporosis.

Asthma is a chronic disease of the respiratory tract characterized by inflammatory processes. Generics of asthma medication are usually just as effective as the more expensive branded drugs. High blood pressure, also known as hypertension, affects many people and can lead to serious complications. Here are generics are a cost-effective alternative to the more expensive branded drugs.

Also for diabetes, both type 1 and type 2 generics are also used. As many people suffer from this metabolic disorder, generics allow generics a cost-effective therapy. Osteoporosis is a disease in which the bone density and structure decreases. Generics of osteoporosis medication are also available and help to slow down the progression of the disease.

Generics are also used to treat serious cancers. Here they give patients access to vital medicines at an affordable price. Generics have proven to be a reliable and effective option in medical practice to treat various diseases. Due to their affordability, they improve patients' quality of life and ensure they receive adequate therapy.

Is the switch from the original to the generic harmless?

Switching from the original medicine to the generic is harmless, since generics offer the same safety and efficacy as branded drugs. Generics are approved by the Federal Institute for Drugs and Medical Devices (BfArM) or the European Medicines Agency (EMA) and contain the identical active ingredient in the same quality and dosage as the original preparation.

The slight differences between generics and original preparations lie in the excipients and the manufacturing process. However, these differences have no influence on the efficacy or safety of the medicine. The excipients are only responsible for the packaging, the taste or the shelf life of the medicine and can vary depending on the manufacturer.

It is important to emphasize that the change from the original to the generic does not entail any risks or disadvantages for patients. Generics are just as safe and effective as their branded counterparts. They offer a more cost-effective alternative, as the manufacturers of generics do not have high development costs and can therefore offer lower prices. The switch to generic is therefore a sensible step to save costs without compromising the quality or efficacy of the drug.

Why are generics so cheap?

Generics are inexpensive imitation products of branded medicines. They differ from the original drugs primarily in their lower price. But why are generics so cheap?

The main reason for the lower costs is that generic manufacturers do not have to conduct expensive clinical research. The development of a new drug requires many years of research and testing, which incurs high costs. However, generic manufacturers use existing information about the effectiveness of the original drug. They can rely on efficacy studies that have already been carried out for the branded drug. This saves them a lot of time and money.

Another reason for the lower costs of generics is competition. As soon as the patent for a branded drug has expired, other companies can generics can produce generics. This leads to increased competition, which lowers prices. The market for generics is often very competitive, as many companies try to capture the largest share of the market.

Overall generics are a cost-effective alternative to branded drugs. By foregoing clinical research, utilizing existing efficacy studies and the competitive factor, generic manufacturers can reduce prices and provide patients with affordable treatment.

Why do patients sometimes get the drug from a different manufacturer than they are used to?

Patients occasionally receive a drug from a different manufacturer than they are used to for a variety of reasons. One of these reasons has to do with discount agreements between health insurance companies and pharmaceutical manufacturers. Under these contracts, insured persons may only be supplied with medicines from the contract manufacturer. This means that the health insurance company lowers the price of the medication by concluding a contract with a specific manufacturer. Based on this agreement, patients then only receive the medication from the contract manufacturer. This can lead to a change in the brand of the medicine.

Another reason why patients may need a generic of an over-the-counter medicine is that it is possible to obtain generics are a cost-effective alternative to branded drugs. Generics contain the same active ingredient as the branded drug, but are usually significantly cheaper. This allows patients to save money, especially if their health insurance does not provide reimbursement for the branded drug. For this reason, many doctors and pharmacists automatically choose the genericunless the patient expressly requests the branded drug.

In summary, it can be said that patients occasionally receive a preparation from another manufacturer, as this may be related to discount agreements between health insurance companies and pharmaceutical manufacturers, under which insured persons may only be supplied with medicines from the contract manufacturer. In addition, patients can generics of over-the-counter medicines, as these represent a cost-effective alternative to the more expensive branded medicines.

Source: istockphoto izusek

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